Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) → EGS — Handpiece, Contra- And Right-Angle Attachment, Dental # EGS · Handpiece, Contra- And Right-Angle Attachment, Dental _Dental · 21 CFR 872.4200 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS ## Overview - **Product Code:** EGS - **Device Name:** Handpiece, Contra- And Right-Angle Attachment, Dental - **Regulation:** [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. ## Classification Rationale Class I. ## Recent Cleared Devices (20 of 73) Showing 20 most recent of 73 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251869](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K251869.md) | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | Sep 15, 2025 | SESE | | [K240950](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K240950.md) | Disposable Prophy Angle | Pacific Care Limited | May 28, 2025 | SESE | | [K240183](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K240183.md) | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | Sep 19, 2024 | SESE | | [K230106](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K230106.md) | General Cutting Straight | Nakanishi, Inc. | May 24, 2023 | SESE | | [K222518](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K222518.md) | FX Contra | Nakanishi, Inc. | Nov 17, 2022 | SESE | | [K220874](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K220874.md) | Smooth Drive contra angle and straight handpieces | Lares Research | Nov 7, 2022 | SESE | | [K220346](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K220346.md) | Lotus Prophy Angle | Ajk Engineering, Inc. | Nov 7, 2022 | SESE | | [K220577](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K220577.md) | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | Jul 29, 2022 | SESE | | [K213139](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K213139.md) | SURGmatic S15 L Pro | Kavo Dental GmbH | Dec 21, 2021 | SESE | | [K202960](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K202960.md) | General Cutting Contra Handpiece | Nakanishi, Inc. | Oct 27, 2020 | SESE | | [K182892](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K182892.md) | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | Nov 26, 2019 | SESE | | [K182999](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K182999.md) | General Cutting Contra Handpiece | Nakanishi, Inc. | Apr 16, 2019 | SESE | | [K181129](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K181129.md) | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jan 31, 2019 | SESE | | [K171436](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K171436.md) | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jan 5, 2018 | SESE | | [K162856](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K162856.md) | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | Jul 18, 2017 | SESE | | [K162397](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K162397.md) | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | Jan 19, 2017 | SESE | | [K133178](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K133178.md) | LUXATOR LX HANDPIECE | Directa AB | Nov 24, 2015 | SESE | | [K143418](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K143418.md) | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jul 31, 2015 | SESE | | [K150750](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K150750.md) | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | Jul 2, 2015 | SESE | | [K141125](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS/K141125.md) | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | Oct 23, 2014 | SESE | ## Top Applicants - Nakanishi, Inc. — 5 clearances - Saeshin Precision Co., Ltd. — 5 clearances - Micro-Mega Societe Anonyme — 4 clearances - Angstrom Mfg., Inc. — 2 clearances - Aseptico, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com